Dialysis product is recalled and may pose fatal risks

A product manufactured by the nation’s largest for-profit dialysis chain put patients at risk of heart attacks and sudden cardiac death, according to a recall issued by federal authorities.

The product, GranuFlo, is an ingredient in the solution inside the dialysis machine that helps clean the blood of kidney patients. It is made by Fresenius, which provides dialysis services to 2.1 million people worldwide and also manufactures and sells dialysis machines and supplies to its centers and others.

Fresenius, based in Germany, owns 50 of New Jersey’s 130 dialysis centers, including facilities in Englewood, Teaneck and Fair­view. Many other facilities in New Jersey have used GranuFlo.

According to an internal company memo provided to the Food and Drug Administration anonymously and posted on the federal agency’s website, GranuFlo may have played a role in 941 cardiac deaths at some 670 Fresenius-owned facilities in North America in 2010. The facilities were not named.

“There is a reasonable probability that use of these products will cause serious adverse health consequences or death,” the FDA said in June. The FDA is also looking into why there was a months-long lag between the time the company notified the dialysis centers it owns of the problem and when it told other centers that use GranuFlo, a spokeswoman said.

Although the FDA declared a Class 1 recall, the agency’s most serious, it is not requiring GranuFlo to be taken off the shelves, said Sarah Clark-Lynn, an FDA spokes­woman. Instead, Fresenius is required to relabel the product and update the operating manuals for the dialysis machines.

GranuFlo is still being used because there may be an insufficient supply of alternative products. “There’s very little choice in terms of volume of readily available products that can be used,” said Gary Peterson, founder of RenalWEB, an independent news service for the dialysis industry that first reported the problems with GranuFlo in March.

Fresenius said in a statement that 90 percent of its customers had been notified. The company is continuing “its process to place updated labels” on its products and “update its hemodialysis machine operator’s manuals,” the statement said.

Local centers that are not owned by Fresenius reacted to the FDA’s action in varied ways.

Dr. Tom Parker, a Dallas nephrologist and the chief medical officer of Renal Ventures, a multi-state chain that owns dialysis centers in Westwood and Clifton, said his company “responded immediately” to the recall to protect patients. “We immediately advised our physicians of these memos, and then further advised them of the FDA recall,” he said.

Holy Name Medical Center’s dialysis unit did not use GranuFlo, said Jane Ellis, a hospital vice president. No one was available to answer questions about the use of the product at The Valley Hospital’s two dialysis centers, a spokeswoman said.

DaVita Inc., which owns 26 dialysis centers in the state, including those formerly owned by St. Joseph’s Regional Medical Center and Hackensack University Medical Center, declined to disclose whether the company used the recalled product. A spokesman said that “we are not currently aware of any patient impact as the result of this issue.”

“The manufacturer and the FDA recently made us aware of a Class 1 product recall,” said the spokes­man, Vince Hancock. “We have worked diligently to follow the necessary steps outlined in the recall notice.”

The FDA’s action comes as ownership of dialysis centers is becoming consolidated among a handful of for-profit companies, a trend that has accelerated in North Jersey in recent months with the sale of dialysis centers at most non-profit hospitals to either Fresenius or DaVita, the nation’s second-largest chain. At the same time, demand for dialysis, a largely government-funded treatment for kidney failure, is growing.

The recall raises questions about the effects of such concentration on accountability and patient safety. “Is there not a dangerous conflict of interest for a company that treats patients and makes the products as well?” Peterson said.

Dr. Jeffrey S. Berns of the University of Pennsylvania School of Medicine was so concerned about the GranuFlo situation, he posted an online video editorial asking, “Are we failing our dialysis patients?” “One needs to question whether or not Fresenius had an opportunity to limit exposure to the solution earlier than it did,” he told The Record. “I don’t really know that. I suspect that will be investigated.”

Physicians also must take some responsibility, he said. They may not have been aware of the potential harm of using the product. “Patients would be better served,” he added, if their kidney specialists “had a greater ownership of assuring the quality of care and quality of outcomes.”

GranuFlo is a concentrated powder that is mixed with water to form an acid solution in the dialysis machine. The acid solution is combined with a bicarbonate solution to make “dialysate,” which passes through the machine’s artificial kidney as it cleans the blood.

In November, in response to what the memo called “troubling findings” about the deaths, Fresenius recommended to the centers it owned that they adjust the dialysate prescription for individual patients, based on blood tests.

But Fresenius did not warn the medical directors of other facilities that use the product until March — a delay the FDA is investigating, according to Clark-Lynn.

“We continue to evaluate Fresenius’ actions,” she said.

Parker, who is on the medical advisory board of the American Association of Kidney Patients, said Fresenius’ sheer size enabled the company to detect the problem. “I don’t know whether a small company could figure something like this out,” he said. “It takes a huge number of patients — in order to make this statistical calculation.”

An estimated 260,000 patients — slightly more than half of them at Fresenius facilities — were using GranuFlo in May and sales of the product totaled more than $80 million annually, Peterson estimated.

Joseph Santoli, a Ridgewood product-liability attorney, said the recall has touched off “a feeding frenzy” among lawyers who want to represent patients who suffered heart attacks or their survivors. Santoli, who was involved in previous lawsuits involving the all-metal hip replacement and the diet pill combination fen-phen, is one of several attorneys who have set up websites — his is “DialysisRecall.com” — seeking to identify such patients.

“It’s just an indication of a larger problem that’s been resulting from a runaway system, where centers are controlled by two players — it’s almost like a take-it-or-leave-it attitude,” Santoli said.

The need for dialysis has grown along with the nation’s epidemic of obesity, a condition that can lead to diabetes, high blood pressure and, ultimately, kidney failure. When the kidneys no longer work, dialysis is needed to cleanse the blood — an often exhausting process that takes several hours, three days a week. Medicare pays for the treatment of the majority of the 400,000 dialysis patients in the United States, at a public cost of more than $20 billion a year.

Sudden cardiac death is a leading cause of death among dialysis patients in the United States.

Fresenius’ internal memo found a “6 to 8 fold greater risk of cardiopulmonary arrest and sudden cardiac death in the dialysis facility” among certain patients.

These were identified as patients whose blood tests showed higher levels of bicarbonate before dialysis. The problem with GranuFlo was that it contained an ingredient that increased the bicarbonate levels, and most doctors weren’t aware of its possible adverse effects.

The memo “strongly recommended” that physicians review their patients’ blood chemistries monthly, and individualize their prescriptions for the dialysis chemicals accordingly.

“People shouldn’t be having heart attacks during dialysis,” said Joe Atkins, a dialysis nurse and founder of a medical device company in Ohio. “Dialysis should be a routine thing, uneventful.”

Dialysis product is recalled and may pose fatal risks

A product manufactured by the nation’s largest for-profit dialysis chain put patients at risk of heart attacks and sudden cardiac death, according to a recall issued by federal authorities.

The product, GranuFlo, is an ingredient in the solution inside the dialysis machine that helps clean the blood of kidney patients. It is made by Fresenius, which provides dialysis services to 2.1 million people worldwide and also manufactures and sells dialysis machines and supplies to its centers and others.

Fresenius, based in Germany, owns 50 of New Jersey’s 130 dialysis centers, including facilities in Englewood, Teaneck and Fair­view. Many other facilities in New Jersey have used GranuFlo.

According to an internal company memo provided to the Food and Drug Administration anonymously and posted on the federal agency’s website, GranuFlo may have played a role in 941 cardiac deaths at some 670 Fresenius-owned facilities in North America in 2010. The facilities were not named.

“There is a reasonable probability that use of these products will cause serious adverse health consequences or death,” the FDA said in June. The FDA is also looking into why there was a months-long lag between the time the company notified the dialysis centers it owns of the problem and when it told other centers that use GranuFlo, a spokeswoman said.

Although the FDA declared a Class 1 recall, the agency’s most serious, it is not requiring GranuFlo to be taken off the shelves, said Sarah Clark-Lynn, an FDA spokes­woman. Instead, Fresenius is required to relabel the product and update the operating manuals for the dialysis machines.

GranuFlo is still being used because there may be an insufficient supply of alternative products. “There’s very little choice in terms of volume of readily available products that can be used,” said Gary Peterson, founder of RenalWEB, an independent news service for the dialysis industry that first reported the problems with GranuFlo in March.

Fresenius said in a statement that 90 percent of its customers had been notified. The company is continuing “its process to place updated labels” on its products and “update its hemodialysis machine operator’s manuals,” the statement said.

Local centers that are not owned by Fresenius reacted to the FDA’s action in varied ways.

Dr. Tom Parker, a Dallas nephrologist and the chief medical officer of Renal Ventures, a multi-state chain that owns dialysis centers in Westwood and Clifton, said his company “responded immediately” to the recall to protect patients. “We immediately advised our physicians of these memos, and then further advised them of the FDA recall,” he said.

Holy Name Medical Center’s dialysis unit did not use GranuFlo, said Jane Ellis, a hospital vice president. No one was available to answer questions about the use of the product at The Valley Hospital’s two dialysis centers, a spokeswoman said.

DaVita Inc., which owns 26 dialysis centers in the state, including those formerly owned by St. Joseph’s Regional Medical Center and Hackensack University Medical Center, declined to disclose whether the company used the recalled product. A spokesman said that “we are not currently aware of any patient impact as the result of this issue.”

“The manufacturer and the FDA recently made us aware of a Class 1 product recall,” said the spokes­man, Vince Hancock. “We have worked diligently to follow the necessary steps outlined in the recall notice.”

The FDA’s action comes as ownership of dialysis centers is becoming consolidated among a handful of for-profit companies, a trend that has accelerated in North Jersey in recent months with the sale of dialysis centers at most non-profit hospitals to either Fresenius or DaVita, the nation’s second-largest chain. At the same time, demand for dialysis, a largely government-funded treatment for kidney failure, is growing.

The recall raises questions about the effects of such concentration on accountability and patient safety. “Is there not a dangerous conflict of interest for a company that treats patients and makes the products as well?” Peterson said.

Dr. Jeffrey S. Berns of the University of Pennsylvania School of Medicine was so concerned about the GranuFlo situation, he posted an online video editorial asking, “Are we failing our dialysis patients?” “One needs to question whether or not Fresenius had an opportunity to limit exposure to the solution earlier than it did,” he told The Record. “I don’t really know that. I suspect that will be investigated.”

Physicians also must take some responsibility, he said. They may not have been aware of the potential harm of using the product. “Patients would be better served,” he added, if their kidney specialists “had a greater ownership of assuring the quality of care and quality of outcomes.”

GranuFlo is a concentrated powder that is mixed with water to form an acid solution in the dialysis machine. The acid solution is combined with a bicarbonate solution to make “dialysate,” which passes through the machine’s artificial kidney as it cleans the blood.

In November, in response to what the memo called “troubling findings” about the deaths, Fresenius recommended to the centers it owned that they adjust the dialysate prescription for individual patients, based on blood tests.

But Fresenius did not warn the medical directors of other facilities that use the product until March — a delay the FDA is investigating, according to Clark-Lynn.

“We continue to evaluate Fresenius’ actions,” she said.

Parker, who is on the medical advisory board of the American Association of Kidney Patients, said Fresenius’ sheer size enabled the company to detect the problem. “I don’t know whether a small company could figure something like this out,” he said. “It takes a huge number of patients — in order to make this statistical calculation.”

An estimated 260,000 patients — slightly more than half of them at Fresenius facilities — were using GranuFlo in May and sales of the product totaled more than $80 million annually, Peterson estimated.

Joseph Santoli, a Ridgewood product-liability attorney, said the recall has touched off “a feeding frenzy” among lawyers who want to represent patients who suffered heart attacks or their survivors. Santoli, who was involved in previous lawsuits involving the all-metal hip replacement and the diet pill combination fen-phen, is one of several attorneys who have set up websites — his is “DialysisRecall.com” — seeking to identify such patients.

“It’s just an indication of a larger problem that’s been resulting from a runaway system, where centers are controlled by two players — it’s almost like a take-it-or-leave-it attitude,” Santoli said.

The need for dialysis has grown along with the nation’s epidemic of obesity, a condition that can lead to diabetes, high blood pressure and, ultimately, kidney failure. When the kidneys no longer work, dialysis is needed to cleanse the blood — an often exhausting process that takes several hours, three days a week. Medicare pays for the treatment of the majority of the 400,000 dialysis patients in the United States, at a public cost of more than $20 billion a year.

Sudden cardiac death is a leading cause of death among dialysis patients in the United States.

Fresenius’ internal memo found a “6 to 8 fold greater risk of cardiopulmonary arrest and sudden cardiac death in the dialysis facility” among certain patients.

These were identified as patients whose blood tests showed higher levels of bicarbonate before dialysis. The problem with GranuFlo was that it contained an ingredient that increased the bicarbonate levels, and most doctors weren’t aware of its possible adverse effects.

The memo “strongly recommended” that physicians review their patients’ blood chemistries monthly, and individualize their prescriptions for the dialysis chemicals accordingly.

“People shouldn’t be having heart attacks during dialysis,” said Joe Atkins, a dialysis nurse and founder of a medical device company in Ohio. “Dialysis should be a routine thing, uneventful.”